IRB Manual
  1.2 Definitions
   
Actively Involved: Sufficient and ongoing involvement in a person's life so as to have sufficient knowledge of the person's needs.

Actively Involved Family Member: Someone 18 years of age or older who is related to a person in a facility and who has demonstrated, in the opinion of the treatment team/program planning team, significant and ongoing involvement in a person's life, as well as sufficient knowledge of the person's individual needs.

Advocate: An individual appointed by the IRB, or through procedures approved by the IRB, to act in the best interests of the subject.

American Indian or Alaskan Native: A person having origins in any of the original peoples of North America, and who maintains cultural affiliation through tribal affiliation or community recognition.

Asian or Pacific Islander: A person having origins in any of the original peoples of the Far East, Southeast Asia, the Indian subcontinent, or the Pacific Islands. This area includes, for example, China, India, Japan, Korea, the Philippine Islands and Samoa.

Assent: A subject's affirmative agreement to participate in research. (Mere failure to object should not, in the absence of affirmative agreement, be construed as assent.)

Black, not of Hispanic Origin: A person having origins in any of the black racial groups of Africa.

Capacity: Capacity means the subject’s ability to understand the purpose, nature, risks, benefits and alternatives (including non-participation) of the research, to make a decision about participation, and to understand that the decision about participation in the research will involve no penalty or loss of benefits to which the subject is otherwise entitled.

Certification: The official notification by the institution to the Department of Health and Human Services in accordance with the Department of Health and Human Services Regulations for the Protection of Human Subjects, that a research project or activity involving human subjects has been reviewed and approved by the IRB in accordance with its approved assurance.

Children : Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. That is (for NY), a person under the age of 18 years, except that a person under the age of 18 who is on voluntary status on his own application (OMH), or who is married or the parent of a child is considered to be an adult for the purpose of consenting to research participation.

Dead Fetus: A fetus ex utero which exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

Delivery:  Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.

DHHS:  Department of Health and Human Services.

Engaged in Research:  When employees or agents of an institution (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes.

FDA: Federal Food and Drug Administration.

Fetus: The product of conception from the time of implantation until delivery.

FWA:  Federal Wide Assurance.

Guardian: An individual who is authorized under applicable State or local law to consent on behalf of a child or incapable adult to general medical care.

Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

HIPAA:  Health Insurance Portability and Accountability Act of 1996

Hispanic: A person of Mexican, Puerto Rican, Cuban, Central or South American, or other Spanish culture or origin, regardless of race.

IDE: An Investigational Device Exemption issued by the Food and Drug Administration according to 21 CFR 812 & 813.

IND: An Investigational New Drug exemption issued by the Food and Drug Administration according to 21 CFR 312.

Informed Consent: The legally effective, knowing consent of an individual, or his legally authorized representative, with sufficient capacity to consent and so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion.

Institution: Any public or private entity or agency (including Federal, State and other agencies).

IRB: Institutional Review Board.

IRB Approval: Means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional, federal and state requirements.

Interaction: Includes communication or interpersonal contact between the investigator and the subject.

Intervention: Physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Minimal Risk: For the purposes of Subpart C - Research Involving Prisoners: The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

Neonate:  newborn

Nonviable Neonate: A neonate ex utero which, although living, is not viable.

OHRP: Office for Human Research Protections, formerly OPRR, (part of the Federal Department of Health and Human Services).

Parent: A child's biological or adoptive parent.

Participant: For the purposes of 633.13 (OMRDD Regulations) only, a person or any other party with developmental disabilities receiving services from the facility (e.g., those occupying respite or temporary use beds) and who are involved in any research project.

Permission: The agreement of parent(s) or a guardian to the participation of their child or ward in research.

Pregnancy: Encompasses the period of time from confirmation of implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.

Prisoner: Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced in such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, individuals detained pending arraignment, trial or sentencing and individuals who are on parole. (Note: this definition includes some DMH patients/clients. See Section 7.5)

Private Information: Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for a specific purpose by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject may readily be ascertained by the investigator or is associated with the information).

Research: A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research whether or not they are conducted or supported under a program which is considered research. Some "demonstration" or "service" programs may include research activities. Generalizable knowledge may be expressed, for example, in theories, principles, and statements of relationships.

RFMH: The Research Foundation for Mental Hygiene, Inc., a not-for-profit corporation affiliated with the New York State Department of Mental Hygiene.

Viable:  As it pertains to the neonate means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heart beat and respiration. The Secretary DHHS may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a neonate is viable for the purposes of 45 CFR 46 Subpart B. If a neonate is viable then it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of 45 CFR 46.

     
   


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